【正文】 Harbin Pharmaceutical Group Co., Ltd. General Pharm. Factory哈藥集團(tuán)制藥總廠Performance Qualification (PQ) Protocol性能確認(rèn)(PQ)方案Equipment ：EUSBS07：PQPEUUT002Project Name項目名稱Manufacture Name制造商名稱Index目錄1. Introduction介紹 52. Purpose目的 73. Scope范圍 8 Scope范圍內(nèi) 8 Exclusion of Scope范圍外 94. Responsibilities職責(zé) 9 Austar Responsibilities奧星職責(zé) 9 HGPF Responsibilities哈藥總廠職責(zé) 95. Abbreviations縮略語 116. Regulation and Guidance法規(guī)和指南 137. References參考文件 148. System Description系統(tǒng)/設(shè)備描述 19 System Use系統(tǒng)用途 19 Operation and Design Features運(yùn)行和設(shè)計特點 229. Validation Strategy驗證策略 25 Performance Qualification Flow性能確認(rèn)流程 25 PQ sampling plan性能確認(rèn)取樣計劃 2510. Documentation Control Specification文件管理規(guī)范 3911. Test List測試項目列表 4312. Performance Qualification Tests性能確認(rèn)測試 45 Prerequisites Verification先決條件確認(rèn) 45 Personnel Verification人員確認(rèn) 47 SOP Verification SOP確認(rèn) 48 Training Verification培訓(xùn)確認(rèn) 51 Testing Instrument Calibration Verification測試用儀器儀表校準(zhǔn)確認(rèn) 53 System Operation Parameters Verification系統(tǒng)運(yùn)行參數(shù)確認(rèn) 55 Sanitization Verification消毒確認(rèn) 56 The Water quality for pretreatment System Verification預(yù)處理水質(zhì)認(rèn) 59 PW Quality Verification純化水質(zhì)量確認(rèn) 6113. Deviation Handling偏差處理 6614. Change Handling變更處理 6615. Summary of PQ性能確認(rèn)總結(jié) 6616. List of Attachment測試報告附件 68Test Report 1 測試報告1 70Test Report 2 測試報告2 74Test Report 3 測試報告3 76Test Report 4 測試報告4 79Test Report 5 測試報告5 81Test Report 6 測試報告6 83Test Report 7 測試報告7 86Test Report 8 測試報告8 88Test Report 9 測試報告9 911. Introduction介紹Harbin Pharmaceutical Group General Pharmaceutical Factory (hereinafter called HGPF) is establishing a new production building in accordance with the Chinese GMP and EU GMP requirements. Shanghai Austar is responsible for detailed design and construction of new Purified Water Generation Storage and Distribution System in this plant, and it is used for providing water for production of sterile powder for injection on second floor and QC lab on forth floor. This system is designed for circulating 24hours, and sterilized by pasteurization for one hour each time. It has emptying ability and 33 points of use. A set of , and the generated PW is stored in a 6m3 vertical storage tank. Control system can monitor critical parameter of conductivity on line. It has the functions of automatic alarm and automatic discharging of water out of specification. When the generation stopped, volume of purified water in the system can still be use for about 1 day.哈藥集團(tuán)制藥總廠（以下簡稱哈藥總廠）正在新建一個滿足中國GMP和歐盟GMP的生產(chǎn)樓。該車間新建純化水制備、儲存和分配系統(tǒng)由上海奧星制藥裝備有限公司負(fù)責(zé)詳細(xì)設(shè)計和施工，主要用于二樓無菌粉針的生產(chǎn)和四樓化驗室用水。該系統(tǒng)設(shè)計為24小時循環(huán)系統(tǒng)，采用1小時巴氏消毒，并保證有排空能力，該系統(tǒng)共有33個使用點。，制備的純化水貯存在一個容積6m3的立式儲罐內(nèi)?？刂葡到y(tǒng)對純化水的關(guān)鍵參數(shù)如電導(dǎo)率能夠進(jìn)行在線監(jiān)控，有自動報警和超標(biāo)自動排放功能。當(dāng)供水停止時，儲存和分配系統(tǒng)中的儲水大概可供正常使用1天的時間。The Purified water Generation System (System Number: EUUT001) and Purified water Storage and Distribution System (System Number: EUUT002) is system is determined to be direct impact system according to system impact assessment method. See SIAREU201100.該純化水制備系統(tǒng)（系統(tǒng)編號EUUT001）和純化水儲存和分配系統(tǒng)（系統(tǒng)編號EUUT002）根據(jù)系統(tǒng)影響評估的方法確定為直接影響系統(tǒng)，見SIAREU201100。Before Performance Qualification of Purified water System is performed, Installation Qualification and Operation Qualification should have been pleted. Installation Qualification of Purified water Generation System (Document No.: IQREUUT001, Version: 0). Installation Qualification of Purified water Storage and Distribution System (Document No.: IQREUUT002, Version: 0). Operational Qualification of Purified water Generation System (Document No.: OQREUUT001, Version: 0). Operational Qualification of Purified water Storage and Distribution System (Document No.: OQREUUT002, Version: 0).該純化水系統(tǒng)的性能確認(rèn)前，安裝確認(rèn)和運(yùn)行確認(rèn)應(yīng)該已經(jīng)已經(jīng)完成。純化水制備系統(tǒng)安裝確認(rèn)報告（報告名稱：IQREUUT001，版本:0）；純化水儲存和分配系統(tǒng)安裝確認(rèn)報告（報告名稱：IQREUUT002，版本:0）；純化水制備系統(tǒng)運(yùn)行確認(rèn)報告（報告名稱：OQREUUT001，版本:0）；純化水儲存和分配系統(tǒng)運(yùn)行確認(rèn)報告（報告名稱: OQREUUT002，版本:0）。2. Purpose目的This Performance Qualification is prospective validation of new Purified Water System of EU Powder for Injection Plant.本性能確認(rèn)為EU粉針車間純化水儲存和分配系統(tǒng)新建后前驗證。The purpose of this Performance Qualification Protocol is to provide documented evidence to verify that Purified Water System, used in new EU Powder for Injection Plant of HGPF can consistently produce qualified purified water in pliance with requirements specified in Chinese Pharmacopoeia 2010 , and to determine the applicability of SOP for purified water System and continuous stability of system operation. 本性能確認(rèn)方案的目的是提供文件證據(jù)證明哈藥總廠新建EU粉針車間內(nèi)純化水系統(tǒng)能持續(xù)產(chǎn)出符合中國藥典CP 2010版的相關(guān)規(guī)定和要求的純化水，并確定純化水系統(tǒng)SOP的適用性和系統(tǒng)設(shè)備運(yùn)行的持續(xù)穩(wěn)定性。Performance test shall be performed under real production condition, and verification data shall be collected and recorded in attached test report. PQ is the last step of formal test and providing documented evidence for system (for which PQ is required in qualification requirement matrix) with correct performance before formal operation. When the final PQ report is approved, this system can be used for normal production operation or process validation.性能測試應(yīng)在真實生產(chǎn)條件下進(jìn)行，應(yīng)收集確認(rèn)數(shù)據(jù)并記錄在附件的測試報告上。PQ是正式測試的最后步驟，以及確認(rèn)需求矩陣中識別為進(jìn)行PQ測試的系統(tǒng)正式運(yùn)行前正確性能的文件證據(jù)。當(dāng)最終PQ報告批準(zhǔn)后，系統(tǒng)可用于正常生產(chǎn)操作或用于工藝驗證。3. Scope范圍 Scope范圍內(nèi)The scope of this Performance Qualification includes the Purified Water Generation System (System Number: EUUT001) and Purified Water Storage and Distribution System (System Number: EUUT002). It will be performed in the method of three phases. Sampling plan of Phase 1 and Phase 2 and sanitization qualification of Phase 1, Phase 2 and Phase 3 the three phases are described in details in this Protocol.本性能確認(rèn)的范圍為哈藥總廠EU粉針車間純化水制備系統(tǒng)（系統(tǒng)編號EUUT001）和純化水儲存和分配系統(tǒng)（系統(tǒng)編號EUUT002）。該純化水系統(tǒng)將按照三階段法進(jìn)行，本方案詳細(xì)描述了性能確認(rèn)階段1和階段2的取樣計劃和階段階段階段3，三個階段消毒確認(rèn)。 Exclusion of Scope范圍外The followings are not included in this Performance Qualification Protocol:下述內(nèi)容未包含在本性能確認(rèn)方案中：252。 The Phase 3 Performance Qualification shall take samples as per the routine monitoring plan of HGPF EU Powder for Injection Plant, and the sampling plan of Phase 3